Alcami recently contributed to an eBook produced by Drug Development and Delivery. The eBook, titled "Analytical Testing in Drug Development," features four companies and explains how they each help the pharmaceutical and biotech industries comply with drug development regulatory requirements. 

Angela Moore, abuse-deterrence studies subject matter expert at Alcami, contributed to the eBook. Her article focuses on considerations for abuse-deterrent Category 1 studies as well as standard syringeability studies.

Join Alcami on Wednesday, September 18, 2019 to learn more about rapid sterility. 

Rapid sterility is an alternative test method to the US Pharmacopeia (USP) General Chapter <71>, Ph.Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. Alcami is launching rapid sterility via the Milliflex^® Rapid System, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after 5 days. A fully comprehensive comparability study verifies adherence to USP/Ph.Eur. requirements for alternative microbiological methods and demonstrates that rapid sterility is a reliable alternative to the reference method.

In this webinar, Alcami’s rapid sterility expert, Stacey Ramsey, will introduce Alcami’s new rapid sterility platform and provide information for understanding implementation requirements. Stacey will also discuss the advantages of the rapid sterility platform as it compares to USP <71>. 

Environmental protection, sustainable conservation, and natural habitat preservation remain key components of Alcami’s community outreach activities, and for the third consecutive year, company volunteers collaborated with Wisconsin Department of Natural Resources (DNR) trail coordinators and park superintendents to improve and renovate the Pike Lake Unit of the Kettle Moraine State Forest – one of the Wisconsin State Park System’s most popular destinations.

The increasing trend of using highly potent active pharmaceutical ingredients (HPAPIs) in new drug development candidates has created a tremendous demand for high containment development and production capabilities.

Alcami is a trusted partner for the development and manufacture of HPAPIs. Our Germantown Center of Excellence for API development, scale up, and commercialization provides an exceptional platform for control strategy at each phase of the development process through a series of investments targeted at infrastructure, workforce, tools, and technology. Alcami’s extensive regulatory expertise allows innovators to execute all parts of development and manufacturing in one US‐based location to support the launch of tomorrow’s medicines.

Name: Michiel Verspagen

Alcami Site: Weert, Netherlands

How long have you been with Alcami?
I have been working for Alcami for 16 years.

What is your role? 
I am an organic chemist in the process research & development laboratory at our Weert, Netherlands site. I develop, adapt, and analyze the chemical synthetic routes used to create new active pharmaceutical ingredients (APIs) and make them suitable for large scale processing in our plant.

What is the most rewarding part of your job? 
Nothing compares to the sheer bliss of scientific discovery. Using new chemical techniques and innovative technologies to overcome the challenges of novel synthetic routes is particularly gratifying to me. The realization that these scientific innovations help bring our customers' drugs to market and might possibly affect the lives of millions of patients in the future makes them even more rewarding.

Alcami will support your animal health products, both companion and livestock, with precise attention to quality by design and process development. We have experience advancing over 50 animal health products from concept through commercialization, with services ranging from analytical support to manufacturing of active pharmaceutical ingredients (APIs), oral solid dose (OSD) products, and sterile (liquid and lyophilized) products. 

Solid state chemistry is fundamental to the development of a pharmaceutical compound into a drug product, and understanding analytics is crucial to successfully addressing any challenges that can occur in a product’s lifecycle. In solid state chemistry specifically, the physical and chemical (PhysChem) analytics will show which properties need to be improved to help ensure the highest chances of success: purity, stability, solubility, or bioavailability.

In drug development, knowing the characteristics of each form of the active pharmaceutical ingredient (API) is essential in order to select the most suitable form for production. For the research chemist, the PhysChem purity is one of the most crucial requirements. Furthermore, selection of the thermodynamically most stable polymorph; low hygroscopicity measured by dynamic vapor sorption (DVS); consistent crystallinity measured using X-ray powder diffraction (XRPD); sharp single melting event determined by differential scanning calorimetry (DSC); and low levels of residual solvent by thermogravimetric analysis (TGA) are all part of the ranking criteria. Aqueous solubility and dissolution rate are indispensable for the route of delivery and dosage form.

Rapid sterility is an alternative test method to the US Pharmacopeia (USP) General Chapter <71>, Ph.Eur. 2.6.1, and JP 4.06 sterility tests that allows for shorter incubation periods and faster results. A typical sterility test has 14 full days of incubation and uses analyst observations to generate results, whereas a rapid sterility test is reduced to just five days of incubation – a 64% reduction in processing time. Rapid sterility also incorporates more sophisticated, computer-generated results, which eliminate observation bias. Alcami utilizes the Milliflex^® Rapid System for the rapid sterility test, which uses adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.

Alcami will be attending the 59th Annual Land O' Lakes Pharmaceutical Analysis Conference August 12 - 15, 2019 in Madison, WI. Be sure to stop by our booth and connect with our team to learn more about Alcami.

Alcami will also be presenting on Wednesday, August 14, 2019 at 12:00 pm. The presentation is titled: Applying the Regulatory Framework for Extractables and Leachables in the Laboratory. 

Name: Shakia Carlos-Barr
Alcami Site: Wilmington, NC

How long have you been with Alcami?
I joined Alcami in May 2018 as an intern, before transitioning to a full-time position in December 2018. 

What is your role? 
Assistant Scientist, Formulations Development-Parenterals

What is the most rewarding part of your job? 
The most rewarding part of my job is knowing that our work gives hope for a better life to patients and their loved ones. In addition, we gain valuable on-the-job knowledge and experience to make us better scientists. This, in turn, helps us develop more innovative solutions that will save lives and lead to higher quality of life for patients worldwide.